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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, coronary, atherectomy
Product CodeMCX
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
8 8 10 5 12 10 13 18 25 14

Device Problems
Entrapment of device or device component 324
No Known Device Problem 275
Fracture 230
Difficult to remove 169
Unknown (for use when the device problem is not known) 144
Device or device component damaged by another device 125
Wire(s), breakage of 112
Device operates differently than expected 92
Detachment of device component 89
No display or display failure 69
Detachment of device or device component 51
Device, or device fragments remain in patient 45
Break 40
Kinked 40
Balloon rupture 39
Foreign material present in device 39
Device damaged prior to use 36
Use of Device Issue 21
Failure to advance 20
Fluid leak 16
Leak 15
Other (for use when an appropriate device code cannot be identified) 15
Tip breakage 15
Device displays error message 15
Aspiration issue 14
No Information 14
Material separation 14
Sticking 13
Difficult to insert 12
Physical resistance 12
Foreign material 11
Stretched 11
Defective component 10
Hole in material 10
Difficult to advance 10
Device Issue 9
Material perforation 9
Tears, rips, holes in device, device material 9
Unstable 8
Malfunction 8
Torn material 8
Unintended movement 6
Device or device fragments location unknown 6
Device stops intermittently 5
Material fragmentation 5
Air leak 5
Bleed back 4
Disconnection 4
Difficult to position 4
Device remains activated 4
Split 4
Device, removal of (non-implant) 3
Device Difficult to Setup or Prepare 3
Decrease in pressure 3
Unsealed device packaging 3
Source, detachment from 2
Shaft break 2
Unraveled material 2
Tear, rip or hole in device packaging 2
Dislodged 2
Contamination during use 2
Declotting 2
Blockage within device or device component 2
Bent 2
Burn of device or device component 2
Dissection 2
Flaked 2
Loose or intermittent connection 2
Delivered as unsterile product 2
High Readings 2
Material deformation 2
Material twisted 2
No flow 1
Pressure issue 1
Gas leak 1
Improper device output 1
Inappropriate or unexpected reset 1
Balloon pinhole 1
Connection issue 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Occlusion within device 1
Output energy incorrect 1
Output above specifications 1
Overheating of device or device component 1
Melted 1
Mislabeled 1
Failure, intermittent 1
Material frayed 1
Failure to flush 1
Bubble(s) 1
Deflation issue 1
Degraded 1
Material discolored 1
Erratic display 1
Incorrect display 1
Device inoperable 1
Failure to select signal 1
Sterility 1
Peeled 1
Total Device Problems 2339

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 2 0
Class II 1 0 0 0 0 0 0 0 0 0
Class III 1 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Nov-13-2015
2 Cardiovascular Systems, Inc. I Mar-20-2015
3 Cardiovascular Systems, Inc. III Feb-26-2014
4 Possis Medical, Inc III Jun-21-2007
5 St Jude Medical CRMD II Jun-14-2007

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